HYPO-BL: Breast Lymphoedema and Radiation Treatment Randomised Controlled Trial – Ultra versus Moderate Breast Hypofractionation Radiation Treatment
Breast Lymphoedema and Radiation Treatment Randomised Controlled Trial – Ultra versus Moderate Breast Hypofractionation Radiation Treatment (HYPO-BL)
Gosford Hospital
200 participants
Aug 12, 2024
Interventional
Conditions
Summary
This study aims to determine the incidence of breast oedema following whole breast radiotherapy using an objective measure of TDC measurements, to determine the difference, if any, between a moderately hypofractionated radiation schedule and an accelerated ultra-hypofractionated schedule. Who is it for? You may be eligible for this study if you are a woman aged 50 years or older and have been diagnosed with breast cancer. Study details Participants will be randomised to one of two possible treatments: the current standard of care of "moderate hypofractionation" treatment, as 40.05 Gy in 15 fractions as daily treatment sessions for 15-19 consecutive days; or " ultra-hypofractionation" treatment, as 26 Gy in 5 fractions to the whole breast, delivered in 5 sessions over 5-9 days. A tumour bed boost is an optional component of both treatments. Participants will be followed for 60 months after the treatment to determine post-radiotherapy breast changes, such as swelling and oedema, quality of life and other patient reported outcomes. It is hoped that this research will help to improve the safety, patient experience, and efficacy of breast cancer treatment.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The study is enrolling 200 patients. If the patient meets the inclusion criteria of the study as per radiation oncologist they can be randomised onto the study via an electronic system. There is a 50/50 chance of being randomised into either arm of the study. Radiotherapy treatment could either be 5-9 or 15-19 days. In the shorter course arm, patients will receive radiotherapy delivered by radiation therapists at Gosford Hospital at a dose of 26.0Gy in five fractions with an optional tumour bed boost (This optional boost is decided by the Radiation Oncologist). This tumour bed boost can be given simultaneously as 30Gy in five fractions or sequentially as 10Gy in four fractions. The overall duration of the intervention is over 5-9 days.
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ACTRN12623001172695